Positive 2-Year Data Reported for Simponi Aria (Golimumab) in Active RA
Nearly 70% of patients demonstrate ACR 20 response (October 28)
New 2-year results from a phase III study have shown that Simponi Aria (golimumab, Janssen) for infusion in combination with methotrexate inhibited radiographic progression in patients with moderately to severely active rheumatoid arthritis (RA) at week 24, and continued to inhibit radiographic progression through weeks 52 and 100.
An analysis of patients’ X-rays showed significant inhibition of the progression of structural damage at week 24 in patients receiving golimumab plus methotrexate compared with patients receiving placebo plus methotrexate. The continued inhibition of structural damage progression was seen in patients randomized to golimumab through weeks 52 and 100, and inhibition of structural damage progression was observed in patients receiving placebo who crossed over to golimumab at weeks 16 or 24.
Treatment with golimumab plus methotrexate also led to improvements in disease activity, with nearly 60% of patients achieving at least a 20% improvement in the American College of Rheumatology (ACR 20) score at week 14 (the study's primary endpoint) and 68% achieving that response at week 100. These data will be presented at the 2013 Annual Meeting of the American College of Rheumatology (ACR).
In July, the FDA approved Simponi Aria (golimumab) for the treatment of adults with moderately to severely active RA in combination with methotrexate. The drug is the only fully human anti-tumor necrosis factor (TNF)-alpha infusible therapy.
Source: PR Newswire; October 28, 2013.